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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Genentech Beth Israel Deaconess Medical Center Brigham and Women's Hospital Massachusetts General Hospital |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00520013 |
The purpose of this research study is to evaluate how patients with newly diagnosed advanced ovarian, fallopian tube, primary peritoneal or papillary serous Mullerian tumor respond to Avastin and erlotinib, or Avastin alone over 1 year. These drugs have been used in the treatment of other types of cancers and information from those studies suggests that these agents may help to treat the cancers studied here.
Condition | Intervention | Phase |
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Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Papillary Serous Mullerian Cancer |
Drug: Avastin Drug: erlotinib Drug: paclitaxel Drug: carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase II Trial of Avastin (A) or Avastin and Erlotinib (AE) as First Line Consolidation Chemotherapy After Carboplatin, Paclitaxel, and Avastin (CTA) Induction Therapy for Newly Diagnosed Advanced Ovarian, Fallopian Tube and Primary Peritoneal Cancer & Papillary Serous Mullerian Tumors |
Estimated Enrollment: | 60 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Avastin every three weeks for 1 year
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Drug: Avastin
Given every three weeks for 1 year
Drug: paclitaxel
Given intravenously on Day 1 of each cycle for 6 cycles (each cycle lasts 21 days)
Drug: carboplatin
Given intravenously on Day 1 of each cycle for 6 cycles (a cycle lasts 21 days)
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2: Experimental
Avastin every three weeks for 1 year and erlotinib every day for one year
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Drug: Avastin
Given every three weeks for 1 year
Drug: erlotinib
Every day for one year
Drug: paclitaxel
Given intravenously on Day 1 of each cycle for 6 cycles (each cycle lasts 21 days)
Drug: carboplatin
Given intravenously on Day 1 of each cycle for 6 cycles (a cycle lasts 21 days)
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The second look surgery is to see if there is any cancer at the end of treatment that was not seen by CT scan or MRI. This surgery will take place about one month after the 6th cycle of treatment if it is recommended.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Susana Campos, MD, MPH | 617-632-6766 | scampos@partners.org |
Contact: Kimberley MacNeill | 617-632-3743 | kmacneill@partners.org |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Susana Campos, MD, MPH | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Principal Investigator: Richard Penson, MD | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Corrine Lenahan, MD |
Principal Investigator: | Susana Campos, MD, MPH | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Susana Campos, MD, MPH ) |
Study ID Numbers: | 07-039 |
Study First Received: | August 22, 2007 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00520013 History of Changes |
Health Authority: | United States: Institutional Review Board |
Fallopian Tube Cancer Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Bevacizumab Protein Kinase Inhibitors Genital Diseases, Female Peritoneal Diseases Ovarian Cancer Endocrine Gland Neoplasms Erlotinib Digestive System Neoplasms Ovarian Neoplasms Genital Neoplasms, Female |
Endocrine System Diseases Carboplatin Antimitotic Agents Abdominal Neoplasms Angiogenesis Inhibitors Fallopian Tube Neoplasms Fallopian Tube Diseases Digestive System Diseases Paclitaxel Tubulin Modulators Gastrointestinal Neoplasms Peritoneal Neoplasms Endocrinopathy Antineoplastic Agents, Phytogenic |
Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Bevacizumab Protein Kinase Inhibitors Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Growth Inhibitors Angiogenesis Modulating Agents Endocrine Gland Neoplasms |
Erlotinib Ovarian Neoplasms Digestive System Neoplasms Growth Substances Mitosis Modulators Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Antimitotic Agents Carboplatin Abdominal Neoplasms Angiogenesis Inhibitors Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases |